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臨床研究における複合結果:再評価の時間

Paul W Armstrong¹, Cynthia M Westerhout²

¹From Canadian VIGOUR Centre, Department of Medicine (Cardiology), University of Alberta, Edmonton, Canada. paul.armstrong@ualberta.ca.

|June 7, 2017

まとめ

心血管試験の複合評価は効率を高めますが,個々の症例の重症性を隠しています. このレビューでは,批判や現在の使用について検討し,より良い臨床試験分析と患者の結果評価のための新しいアプローチを提案しています.

科学分野:

心血管医学
臨床試験の方法論
バイオ統計学

背景:

心血管医学は著しい進歩を遂げ患者の治療結果が改善され死亡率と発病率が低下しました
臨床試験では,効率性のために複数のイベント (死亡,非致命的な合併症など) を組み合わせた複合エンドポイントがますます使用されています.

研究の目的:

心血管疾患の臨床試験における複合エンドポイントの使用を批判的に評価する.
第3段階試験における複合エンドポイントの現在の適用をレビューし,将来の傾向を予測する.
研究における複合エンドポイントの有用性を高めるための新しい方法論を提案する.

主な方法:

複合エンドポイントに対する文献レビュー.
主要コンポジットエンドポイントを用いた,最近発表された第3相心血管試験の分析.
将来の臨床試験データと新興統計学的アプローチの探索

主要な成果:

複合的エンドポイントは,効率的ですが,均一なイベント方向性を仮定し,臨床的意義を区別しません.
現在の臨床試験では最初の症例のみを考慮し複雑な患者の経路を単純化してしまう可能性があります
重要な数の第3相心血管試験では,複合的エンドポイントが採用されており,予想されるよりも多くの結果が出ています.

結論:

心血管試験における複合評価の現在の方法論は,イベントの粒度および臨床的関連性に関して制限があります.
臨床試験の分析において患者の結果の複雑さをよりよく把握するために新しいアプローチが必要である.
将来の研究は,心臓血管医学におけるその価値と精度を高めるために,複合エンドポイント戦略の精錬に焦点を当てるべきです.

キーワード:

心血管疾患臨床試験のテーマとして統計はテーマとして

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